BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3040749 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01837
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 2, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND ADVISED THAT THERE HAS BEEN INTERACTION BETWEEN CERTAIN TYPES OF HOSPITAL EQUIPMENT AND THE MINUTE VENTILATION (MV) FEATURE IN THE DEVICE. THE CALLER WILL REPROGRAM MV TO PASSIVE WHILE THE PATIENT IS ADMITTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD UNDERGONE AN ENDOSCOPIC PROCEDURE AND THE PATIENT'S RATE ACCELERATED TO 140 DURING THE PROCEDURE. A BOSTON SCIENTIFIC SALES REPRESENTATIVE CAME TO THE HOSPITAL AND FOUND THAT IT WAS RATE RESPONSIVE PACING AT THE MAXIMUM SENSOR RATE (MSR). THE DEVICE WAS REPROGRAMMED TO DDD MODE AND THE RATE DROPPED TO THE LOWER RATE LIMIT (LRL). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142987 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S602

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4003M| 7077| 4503M| S602| 1291| 4137| 4469